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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears AMDI's Fast PCR Respiratory Panel With CLIA Waiver for Clinic Use

The four-virus molecular test runs on anterior nasal swabs in under 10 minutes, the company says, and is aimed at urgent care centers and physician offices.

By News DeskJune 19, 20262 min read
Colorized electron micrograph of round influenza virus particles
A colorized transmission electron micrograph of H1N1 influenza virus particles, one of the virus types the panel detects. Not an image of the AMDI test. NIAID, CC BY 2.0, via Wikimedia Commons · CC BY 2.0
FDA cleared510(k) · K252932FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared Autonomous Medical Devices Incorporated's Fast PCR Mini Respiratory Panel under 510(k) K252932 on June 12, 2026, and the company announced a CLIA waiver alongside the clearance.
  • The RT-PCR test detects and differentiates SARS-CoV-2, influenza A, influenza B and RSV from anterior nasal swabs; the company says results take under 10 minutes.
  • In prospective testing at nine CLIA-waived US sites, positive percent agreement ranged from 91.7% for RSV to 100.0% for influenza B, according to the 510(k) summary.

The US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver to Autonomous Medical Devices Incorporated (AMDI) for its Fast PCR Instrument and Mini Respiratory Panel, a molecular test for four common respiratory viruses aimed at urgent care centers and physician offices, LabMedica reported on June 19, citing the Santa Ana, California, company.

The FDA's 510(k) database lists the Fast PCR Mini Respiratory Panel as K252932, received on September 15, 2025, with a substantially equivalent decision on June 12, 2026. The predicate was Cepheid's Xpert Xpress CoV-2/Flu/RSV plus test on the GeneXpert Xpress System. The 510(k) summary lists the device's user complexity as CLIA-waived, the same as the predicate.

What the test does

According to the clearance letter and 510(k) summary, the panel is an automated, multiplexed real-time reverse transcriptase PCR test for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus nucleic acids in anterior nasal swabs from people with signs and symptoms of respiratory tract infection. It is for prescription use. The labeling states that results "should not be used as the sole basis for diagnosis, treatment or other patient management decisions."

AMDI says the system returns results in under 10 minutes. LabMedica reported that the platform is built on the company's proprietary technology with a consumable design that can scale to 32 targets for future test menus, and includes cloud connectivity and electronic health record integration.

Clinical study results

From December 2024 to May 2025, nine CLIA-waived clinical sites in the US tested paired swabs from 1,906 evaluable subjects, the summary states. The test was run by untrained operators using only a quick reference guide, and the comparison swab was frozen and tested at a separate site on an FDA-cleared comparator device.

Across 1,788 prospectively enrolled subjects, positive percent agreement was 97.5% for influenza A, 100.0% for influenza B, 91.7% for RSV and 97.7% for SARS-CoV-2, according to the summary. Negative percent agreement ranged from 97.1% for influenza A to 99.7% for influenza B. Because RSV was uncommon when prospective samples were collected, the study also drew on archived samples.

"Pursuing the FDA's dual 510(k) clearance and CLIA waiver pathway was a deliberate strategy to bring this innovation to market with the validation needed for clinical use in the urgent care setting," Aiying Sun, AMDI's executive vice president for quality, regulatory and clinical affairs, said in the company's announcement, as quoted by LabMedica. The company did not disclose pricing.

Sources

  1. Point-of-Care PCR Panel Detects RSV, Influenza and SARS-CoV-2 in Minutes, LabMedica, June 19, 2026
  2. 510(k) K252932: Fast PCR Mini Respiratory Panel (database record), US Food and Drug Administration, June 12, 2026
  3. K252932 clearance letter and 510(k) summary, US Food and Drug Administration, June 12, 2026